UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002062 |
|---|---|
| Receipt number | R000002515 |
| Scientific Title | Randomized controlled study for an effect of postprandial monitoring with oral hypoglycemic agent in type 2 diabetic patients |
| Date of disclosure of the study information | 2009/06/10 |
| Last modified on | 2009/06/10 16:02:23 |
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Basic information
Public title
Randomized controlled study for an effect of postprandial monitoring with oral hypoglycemic agent in type 2 diabetic patients
Acronym
Effect of postprandial monitoring with oral hypoglycemic agent in type 2 diabetic patients
Scientific Title
Randomized controlled study for an effect of postprandial monitoring with oral hypoglycemic agent in type 2 diabetic patients
Scientific Title:Acronym
Effect of postprandial monitoring with oral hypoglycemic agent in type 2 diabetic patients
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of postprandial monitoring with oral hypoglycemic agent in type 2 diabetic patients.
This study adopt multicenter, open label, randomized controlled design. Subjects are randomized to two groups:one group use the blood glucose-monitoring device, and check the postprandial blood glucose; the control group has standard diabetes treatment.
The primary efficacy parameter is improvement of HbA1c, glucose and lipid metabolism, inflammation, daily care include diet therapy. Secondary efficacy variables include cost reduction by convalescence improvement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c, glucose and lipid metabolism, inflammation, daily care include diet therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Operation of SMBG
Interventions/Control_2
The control group of SMBG(Measurement:post for a fixed period of time)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
HbA1c 5.8-9.0 in non-insulin type 2 diabetic patients
Key exclusion criteria
Insulin patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Munehide Matsuhisa |
Organization
Osaka University School of Medicine
Division name
Department of Endocrinology and Metabolism
Zip code
Address
2-2, yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3633
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Munehide Matsuhisa |
Organization
Osaka University School of Medicine
Division name
Department of Endocrinology and Metabolism
Zip code
Address
2-2, yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3633
Homepage URL
Sponsor or person
Institute
Department of Endocrinology and Metabolism, Osaka University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
johnson and johnson
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2007 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 10 | Day |
Last modified on
| 2009 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002515
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
